Kornimate/medical-research-clean huggingface dataset:
a dose-finding study of pertuzumab (perjeta) in combination with trastuzumab (herceptin) in healthy male participants and women with early breast cancer (ebc)

Conditions: Early Breast Cancer

Summary: this study involves a two-part design. part 1 is designed to determine the optimal dose of subcutaneous (sc) perjeta, injected alone or mixed with herceptin, that results in comparable exposure to intravenous (iv) perjeta. exposure between sc perjeta and iv perjeta will be compared using a compilation of pharmacokinetic (pk) parameters such as area under the concentration-time curve (auc), maximum serum concentration (cmax), time of maximum concentration (tmax), and serum trough concentration (ctrough). part 2 is designed to confirm the dosing regimen in women with ebc on the basis of safety, tolerability, and pk assessments.


Eligibility criteria:
inclusion criteria: * part 1: healthy male volunteers 18 to 45 years of age * part 1: left ventricular ejection fraction (lvef) at least 55 percent (%) * part 1: body mass index (bmi) 18 to 32 kilograms per meter-squared (kg/m\^2) * part 1: normal, intact skin without tattoos or lesions in the injection area * part 2: females at least 18 years of age * part 2: eastern cooperative oncology group (ecog) performance status of 0 * part 2: previously treated, non-metastatic carcinoma of the breast * part 2: baseline lvef at least 55% * part 2: negative pregnancy test and use of adequate contraceptive measures among women of childbearing potential exclusion criteria: * part 1: positive urine test for drugs of abuse * part 1: history of exposure or active viral infection of hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) * part 1: cardiac disease including hypertension or hypotension * part 1: lower extremity edema * part 1: any clinically relevant history of systemic disease * part 1: history of breast cancer * part 1: chronic corticosteroid use * part 1: receipt of iv antibiotics within 7 days prior to enrollment * part 2: concurrent malignancy requiring therapy that may interfere with pharmacokinetic investigations, or history of other malignancy within 5 years prior to screening * part 2: significant cumulative exposure to anthracyclines * part 2: serious cardiac disease including uncontrolled hypertension * part 2: poor hematologic, renal, or hepatic function * part 2: pregnant or lactating women * part 2: history of exposure or active viral infection of hepatitis b, hepatitis c, or hiv * part 2: chronic corticosteroid use * part 2: receipt of iv antibiotics within 7 days prior to enrollment
evaluation of the reasons and consequences of bleeding in late teens and early adulthood patients with severe hemophilia a

Conditions: Hematologic Disease; Blood Coagulation Disorders

Summary: understanding how often the bleeding events occur in the subjects who voluntarily decide to switch from prophylaxis to on-demand and in those subjects who remain on prophylaxis. also look into the consequences of switching treatment in qol (quality of life), development of target joints, activity level and reasons that might influence the desire to switch.


Eligibility criteria:
inclusion criteria: * severe hemophilia a (\<2%) * for subjects who elect staying on prophylaxis only: have been on continuous prophylactic treatment for the past 5 years prior to study entry * for subjects who elect switching to on-demand only: have been on continuous prophylactic treatment for the past 5 years, but may have been on intermediate or reduced prophylaxis for the 1-12 months prior to study entry * for subjects currently on-demand: a retrospective arm of subjects who have been on continuous prophylactic treatment for at least 5 years and switched to on-demand treatment between 13 and 24 months prior to study entry * current treatment with rfviii exclusion criteria: * other known hematological / bleeding disorders other than hemophilia a * participating on another study that may have an impact on bleeding or the objectives of this study * known alcohol and drug abuse
review of descending aortic flow reversal in total anomalous pulmonary venous connection

Conditions: Congenital Disorders

Summary: this is a retrospective review of charts and echocardiograms of our patients with total anomalous pulmonary venous connection (tapvc). the children's surgical and non-invasive echo databases will be used to determine all tapvc patients. children's healthcare of atlanta and sibley heart center cardiology charts and echocardiograms of the tapvc patients between january 1, 2002 and november 26, 2006 will be reviewed. we anticipate approximately 40 patients. we hypothesize that the presence of descending aortic flow reversal correlates with a higher morbidity and mortality in tapvc.

total anomalous pulmonary venous connection (tapvc) is a congenital cardiac anomaly in which the pulmonary veins fail to connect to the usual anatomic location, the left atrium. this may lead to critical cardio-pulmonary failure and extreme cyanosis. this condition usually requires urgent surgical repair. in many cases, the pulmonary veins may be obstructed leading to severe pulmonary hypertension and low cardiac output which may be acutely life-threatening. in these cases, emergent surgical repair is undertaken in the newborn period. patients with tapvc may have poor prognosis which may be difficult to predict. we have made the unusual and previously unreported observation by echocardiography of flow reversal in the upper descending aorta, indicating extremely reduced left ventricular output in patients with tapvc, some of whom have had a poor outcome. this has led to the hypothesis that descending aortic flow reversal portends a poor prognosis in tapvc. the patients with tapvc will be divided into two groups by the presence or absence of descending aortic flow reversal. we, also, would evaluate the presence of other associated cardiac anomalies. the second step of the study would be to review the clinical charts of the above patients to evaluate for serious co-morbidities and mortality. outcome measures would include mortality, chronic lung disease, continued oxygen requirement, recurrent respiratory infections, listing for transplantation, cardiopulmonary arrest or requirement for ecmo.

Eligibility criteria:
inclusion criteria: * children's healthcare of atlanta and sibley heart center cardiology charts and echocardiograms of the tapvc patients between january 1, 2002 and november 26, 2006 will be reviewed. we anticipate approximately 40 patients. the patients with tapvc will be divided into two groups by the presence or absence of descending aortic flow reversal. exclusion criteria: * those who do not fall under the inclusion criteria

Keywords: cardiac anomaly pulmonary veins cyanosis flow reversal tapavc
quantification of upper extremity hypertonia

Conditions: Dystonia; Muscle Hypertonia

Summary: dr. sanger and the research team want to learn about upper extremity hypertonia (stiffness) in children and young adults with cerebral palsy. specifically, they want to learn about ways to measure the stiffness in the joints of hypertonic arms. the information the research team will collect includes any physical exams or computer generated data about your arm movements.


Eligibility criteria:
inclusion criteria:dystonia in at least one arm age 4 to no upper limit exclusion criteria:increased risk of participation botulinum toxin within 6 months
effect and safety of ziprasidone compared to other atypical antipsychotic drug in schizophrenic patients

Conditions: Schizophrenia; Schizoaffective Disorder; Psychotic Disorders

Summary: evaluation of the antipsychotic efficacy and safety of ziprasidone versus olanzapine, risperidone or quetiapine in patients with schizophrenia, schizoaffective and schizophreniform disorders under naturalistic conditions of clinical practice


Eligibility criteria:
inclusion criteria: * inpatients or outpatients with schizophrenia, schizoaffective and schizophreniform disorders (dsm-iv). * patients without adequate current treatment (i.e. intolerance to their current treatment or lack of efficacy of current treatment) based on clinical judgement of the investigator exclusion criteria: * a history of intolerance to ziprasidone, olanzapine, risperidone or quetiapine or any of its ingredients
corneal edema after phacoemulsification

Conditions: Cataract

Summary: to compare the impact of two phacoemulsification techniques (subluxation versus divide-and-conquer) on postoperative corneal edema at postoperative hour 1 and day 4.

phacoemulsification is the procedure of choice for most surgeons performing cataract surgery. alternative techniques have been in development over the last twenty years, with the hope of optimizing operating times, total ultrasound energy used, patient safety, patient satisfaction and visual recovery associated with cataract surgery. divide-and conquer is the parent nucleofracture technique.the subluxation technique is a newer technique that is less frequently used because of an increased risk of corneal endothelium damage. the aim of this comparative study was to evaluate corneal edema immediately after surgery performed with the subluxation technique versus divide-and-conquer. corneal edema was determined by measuring central corneal thickness (cct).

Eligibility criteria:
inclusion criteria: * the presence of a senile cataract with equivalent grades and history of visual acuity regression * informed written consent exclusion criteria: * patients with total white cataract * with history of ocular surgery and other eye diseases (corneal pathology, uveitis, glaucoma) * with systemic diseases with the potential to affect vision

Keywords: subluxation divide and conquer
characterisation of t lymphocytes, nk cells and macrophages in melanoma patients

Conditions: Melanoma

Summary: melanoma tumor tissue ( in particular regressive areas) present a lymphocytic infiltrate with an anti-tumoral specificity. the aim of the study is to analyse at different stages of the disease, tumor samples and to characterise the cellular infiltrate in situ ( in particular t lymphocytes, nk cells and macrophages), the role of inhibitor receptors on in situ immunosuppression, and potential modulation by medical treatments such as dacarbazine.

the study is divided in 4 parts: part 1: study of cellular infiltrate (lymphocytes) performed on large primary melanoma and cutaneous metastasis ( fresh samples) part 2: nk cells study on metastatic regional lymph nodes ( fresh samples) and blood samples part 3: a retrospective study of macrophages in sentinel lymph nodes and in corresponding primary melanomas part 4: study of the cellular modulation by the chemotherapy (dtic or cisplatin or inhibitor of b-raf) which(who) will be made on two cutaneous metastases by patient (one taken before the treatment(processing) and one taken during the evaluation after 2 or 3 cycles of treatment(processing))

Eligibility criteria:
inclusion criteria: * patients with confirmed melanoma-patients informed of the aims of the study , the modalities * patients who signed the consent form ou a non opposition form signed by the patient or by a relative according to study part: part 1: patients with a melanoma larger than 10mm or with cutaneous metastasis part 2: stage iv melanoma patients who shall undergo a regional lymph node dissection part 3: retrospective study of patients who underwent a sentinel node procedure part 4: patients achieves of inoperable melanomas the stage(stadium) iii or iv that must receive in treatment (processing) a chemotherapy (by the dacarbazine or by the cisplatin or by the inhibitor of b-raf) and carrier of at least two cutaneous metastases exclusion criteria: * refusal to take part in the study (patient or relative) * contraindications known to the xylocaine (groups 1,2, and 4) * no affiliated to the social security system (groups 1, 2, and 4)

Keywords: melanoma nk cells t lymphocytes macrophages
the effect of teleyoga in liver transplant patients

Conditions: Liver Transplant Disorder

Summary: online yoga practices will be applied in liver transplant patients and the effects of online yoga on balance, frailty, cognition and quality of life of transplant patients will be examined.

the study will include liver transplant patients who applied to dokuz eylül university faculty of medicine, department of surgical medical sciences, department of general surgery outpatient clinic. the aim of the study is to investigate the effect of online yoga practice on balance, frailty, cognition and quality of life levels in liver transplant patients. the study will include 26 patients with liver transplantation who meet the criteria. participants will first be informed about the study and individuals will be included in the study after signing the informed consent form. demographic information of liver transplant patients will be obtained and their balance, frailty, cognition and quality of life levels and post-transplant symptoms (symptoms seen in people) will be evaluated. online yoga practices will be applied to liver transplant patients for 8 weeks, 2 days a week, 30 minutes a day. online yoga (teleyoga) will be performed via video call with people who meet the inclusion criteria. after 8 weeks of yoga intervention, balance, frailty, cognition and quality of life levels and post-transplant symptoms will be re-evaluated. balance measurements will be evaluated with biodex balance system (bss). frailty levels will be assessed by short physical performance battery and frail frailty questionnaire. cognition will be assessed by trail making test and stroop test. quality of life will be evaluated with short form-36 quality of life scale and post-transplantation symptoms will be evaluated with modified post-transplantation symptom occurrence and discomfort status-58-item scale-turkey. the evaluations are planned to last 1-2 hours.

Eligibility criteria:
inclusion criteria: * being between the ages of 18-65 * liver transplantation at least 6 months ago * individuals with a mini mental test score greater than 24 exclusion criteria: * pregnancy * central nervous system dysfunction * musculoskeletal deformity * vestibular dysfunction * specific neurological pathology (parkinson's, stroke, epilepsy) * those with severe systemic diseases

Keywords: liver transplantation yoga balance cognition
endosure sensor for long-term follow-up after endovascular aaa repair

Conditions: Aortic Aneurysm, Abdominal

Summary: the purpose of this study is to collect and compare endosure and endosure s2 wireless aaa pressure sensor measurements with measurements from ct scan imaging, ultrasound, and other tests used to measure your aaa sac size and endoleaks following aaa repair, and during follow-up visits with your physician. an antenna is held over the patient's abdomen to measure pressure inside the aneurysm sac. the reading does not cause any discomfort, and dye or radiation is not needed to take the pressure measurement. to qualify, the patient must have a previously implanted endosure sensor.


Eligibility criteria:
inclusion criteria: * written informed consent obtained from subject or legal guardian * males or females, at least 18 years of age * subjects who are post-endosure wireless aaa pressure sensor implantation, with pressure measurements at implant. * subjects willing to comply with the site-specific follow-up requirements of the investigator. exclusion criteria: * subjects whose clinical condition, in the investigator's opinion, would not allow them to complete participation in the registry.

Keywords: endosure sensor s2 sensor abdominal aortic aneurysm
treatment with ax200 for acute ischemic stroke

Conditions: Cerebral Stroke

Summary: the axis study is a randomized, double-blind, placebo-controlled, dose-escalating phase iia trial to investigate treatment with ax200 (granulocyte-colony stimulating factor; g-csf) for acute ischemic stroke. the primary objective of the present phase iia study is to assess the safety and tolerability of ax200 compared to placebo in subjects suffering from acute stroke. the secondary objective is to assess the effect of ax200 on subject outcome in comparison to placebo.


Eligibility criteria:
inclusion criteria: * stroke onset within 12 hours prior to start of study agent administration * ischemic stroke in the middle cerebral artery (mca) territory confirmed by magnetic resonance imaging (mri) exclusion criteria: * time interval since stroke onset impossible to determine * carotid t-occlusion (magnetic resonance angiography \[mra\]) * subarachnoid hemorrhages * several safety parameters
prediction of platinum resistance and prognosis of high-grade serous ovarian cancer

Conditions: High-grade Serous Ovarian Cancer (HGSOC)

Summary: high-grade serous ovarian carcinoma (hgsoc) is the most common subtype of ovarian carcinoma. platinum-based drugs are the first-line chemotherapeutic agents for hgsoc, but platinum resistance and prognosis are difficult to predict. domestic and foreign studies have found that multi-functional mri could reflect the macroscopic heterogeneity of tumors from different perspectives; habitat imaging contributed to reflecting the spatial heterogeneity of tumors; the attention mechanism could integrate features of different scales; and multi-omics were capable to improve predictive performance. previously, our team has demonstrated the importance of mri and its functional imaging in the diagnosis and histological evaluation of gynecological tumors. and conventional mri habitat imaging, multi-instance learning based on whole slide image (wsi), and multi-omics model could effectively predict platinum resistance in hgsoc patients. therefore, this study aims to perform habitat imaging on multi-functional mri such as multi b-value dwi and dce-mri and to train wsi-based multi-instance learning to construct pathological signature. then, combined with clinical indicators, radiomics based on mri habitat, and pathomics, a multi-omics fusion model trained by attention mechanism was constructed. finally, to explore the value of mri habitat, wsi, and multi-omics in predicting platinum resistance and prognosis in hgsoc patients. this study combines macroscopic functional imaging and microscopic pathological information to construct a multi-omics complementary model, which can predict platinum resistance and prognosis of hgsoc patients more comprehensively and accurately, and further guide the formulation of clinical treatment.


Eligibility criteria:
inclusion criteria: * patients diagnosed as hgsoc based on surgery and pathology. * the standard treatment including surgical cytoreduction followed by at least three cycles of regular platinum-based chemotherapy after surgery. * follow-up records available for more than six months after postoperative chemotherapy. * for mri analysis, pelvic mri examination including axial t2-weighted imaging (t2wi), contrast-enhanced t1-weighted imaging (ce-t1wi), and diffusion-weighted imaging (dwi) was performed within two weeks prior to treatment, and patients had no any treatments other than neoadjuvant chemotherapy (nact) performed between mri and surgery. exclusion criteria: * patients with a history of platinum-based chemotherapy for other malignancies. * absence of essential clinical data. * for mri analysis, patients with poor mri imaging quality and registration, or a tumor maximum diameter \< 1 cm on mri needed to be excluded. * for pathology analysis, patients without h\&e-stained wsis or with poor wsi imaging quality should be excluded.
to demonstrate the relative bioavailability of azithromycin 600 mg tablets under fed conditions

Conditions: Infection

Summary: to demonstrate the bioequivalence of azithromycin 600 mg tablets under fed conditions.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening exclusion criteria: * positive test results for hiv or hepatitis b or c * treatment for drug or alcohol dependence * female subjects who are pregnant or lactating
bone marrow-derived mesenchymal stem cells (msc) administration in weaning from left ventricular assist device

Conditions: Chronic Myocardial Ischemia

Summary: left ventricular assist devices are commonly used to assist failing hearts as a bridge to transplantation or for long-term support. the purpose of the mesenchymal stem cell therapy and left ventricular assist device program is to improve heart function with stem cell therapy and attempt to wean patients from heartmate left ventricular assist device.

currently left ventricular assist device-only patients are being implanted and followed. feasibility of autologous mesenchymal stem cell grafting in patients receiving heart mate will be assessed in a 4 patient pilot trial. mesenchymal stem cell are delivered during left ventricular assist device surgery by intramyocardial infusions. recovery of contractile function of the heart is assessed during attempts to wean patients from left ventricular assist device

Eligibility criteria:
inclusion criteria: * postmenopausal female or female who may become pregnant but is using adequate contraceptive precautions with negative pregnancy test, * severe left ventricular dysfunction with ejection fraction \< 30% with ischemic cardiomyopathy, * new york heart association class iii or iv, * no revascularization options available, * listed or not for cardiac transplantation, * clinical indication and accepted candidate for left ventricular assistance device implantation as a destination therapy or as a bridge to transplantation, * optimal medical therapy. exclusion criteria: * cardiothoracic surgery within 30 days prior to study entry, * myocardial infarction within 3 months prior to study entry, * prior cardiac transplantation, * left ventricular reduction surgery or cardiomyoplasty, * acute reversible cause of heart failure (e.g. myocarditis, profound hypothyroidism), * left ventricular aneurysm or wall thickness preventing cell injections, * anticipated requirement for biventricular mechanical support, * stroke within 30 days prior to study entry, * received investigational intervention within 30 days of study entry, * pregnant or breastfeeding at time of study entry, * human imune deficiency virus, human t-cell lymphotrophic virus, hepatitis b virus and hepatitis c virus positive within 30 days prior to study entry, * active systemic infection within 48 hours prior to study entry, * history of cancer in the last 5 years, * patient participant to other research, * patient under treatment that may exert an inhibitory or stimulatory effect on the growth and multiplication of cells, or with immunosuppressive properties.

Keywords: left ventricular assist device stem cell therapy ischemic heart failure